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Evaluation of the Bioavailability of Methylprednisolone

NCT05649878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-12-16

No results posted yet for this study

Summary

This study is aimed to evaluate the bioavailability of methylprednisolone in healthy subjects of both genders, with administration intranasally versus intravenous

Conditions

  • Methylprednisone Administration
  • Intranasal Administration
  • Intravenous Administration
  • Healthy Subjects

Interventions

DRUG

Evaluation of bioavailability of methylprednisolone succinate administered intravenously

Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intravenously. The nominal doses were similar, volunteers were randomly assigned to receive a single dose of MEP by IV bolus of 1.5 mL. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.

DRUG

Evaluation of bioavailability of methylprednisolone succinate administered intranasally

Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intranasally. Volunteers were randomly assigned to receive a single dose of MEP intranasally by using a Mucosal Atomization Device (MAD Nasal). allowing direct pharmacokinetic comparison without dose normalization. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.

Sponsors & Collaborators

  • Edda Sciutto Conde

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-05
Primary Completion
2021-11-10
Completion
2021-11-12

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649878 on ClinicalTrials.gov